Quality and compliance are non-negotiable in the realm of Clinical Research. Even the most well organised quality systems are threatened by risks. Stark Associates team with well trained and experienced professionals offer comprehensive, client-specific and robust quality assurance services. Liasioning with all the concerned stakeholders, we assure you with streamlined, effective and impartial audit processes. Our experienced team ensures efficient services in all the quality related aspects of the project, process and the vendor audits.

The tailor-made services and support rendered by us are:

Investigator site audit
  • Preparing the investigator sites for regulatory inspections
  • Mock
TMF audit
  • Preparing and maintaining of the Trial master file
Audit of the clinical data
  • Audit of the clinical database
  • Audit of the clinical study report
Regulatory audit
  • Training on GCP / GLP / GMP
  • Audit of the regulatory submission documents
Process audits
  • Audit of internal and external procedures to promote continuous improvement
  • Identifying the inherent gaps and risks in the procedures followed
  • Mock regulatory inspections and follow-up services
Vendor audits
  • Service providers

Our risk-focused dynamic audit processes focusing on subject safety, data integrity and proactive risk-mitigation strategies will enable you to make well-informed business decisions.